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AAMI TIR30:2011

The AAMI Sterilization Standards Meetings were held on 16-18 October 2017. There were almost 300 medical device manufacturers, FDA personnel, heath care facility personnel, testing laboratory personnel, consultants, and others in attendance.

One item of interest from USFDA/CDRH is that the Office of Device Evaluation (ODE), Office of Compliance (OC), and Office of Surveillance and Biometrics (OSB) are merging into a single structure specified as the Center for Devices and Radiological Health (CDRH) Total Product Life Cycle (TPLC).

AAMI TIR30:2011 Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices is in the process of review and is being rewritten.

ISO/FDIS 17664 – Sterilization of MedicalDevices Information to be provided by the device manufacturer for the processing of reusable medical devices last published in 2004 will be publishing a new version (hopefully by the end of 2017).

A new document currently titled ISO/NP 22913, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Medical devices not intended for direct patient contact, was approved and will be written.

The current draft of ISO 15883-5 – Test soils and methods for demonstrating cleaning efficacy is undergoing a major revision.